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Viral Clearance and Viral Safety

Viral clearance testing is required by regulatory authorities for investigational new drug (IND) submission and is especially critical in process development for biologicals including:

  • Antibodies (monoclonals)
  • Recombinant Proteins and Glycoproteins
  • Tissue and blood-derived products
  • Medical Devices

BioReliance research professionals have performed thousands of viral clearance studies for clients in Biopharma. We can help you rapidly assess the ability of your manufacturing/cleaning processes to produce therapeutics that are safe for use in humans.

Essentially, we ensure your process removes infectious virus particles.

To find the viral clearance assay you need, use the search tool to the right or click here.

 

What types of viruses do we test for prior IND submission?

BioReliance has general screens that detect multiple viruses or specific assays for the following viral strains:

  • Adenovirus viral clearance
  • Retrovirus viral clearance (HIV-1)
  • Parvovirus viral clearance
  • Pseudorabies viral clearance
  • Influenza viral clearance....and many more.

The types of viral strains to be tested are, of course, specific to the method used to manufacture your therapeutic or biological.  For example, Human Influenza A Virus testing should be performed if your test agent is produced in Vero Cells or MDCK Cells.

To find specific viral clearance assays use the search tool to the right or click here

 

What types of assays are used for virus clearance detection?

Viral clearance, also called viral safety or virus clearance, testing can be performed by several methods depending on your biological type, how it is produced, or whether its a medical device.

We routinely utilize qualitative assays for virus particle detection or as complimentary assays to viral clearance titration studies as well as quantitative viral safety assessment.

Examples include - qRT-PCR, PCR, Real Time PCR, ELISA (EIA), Western blot, and transmission EM.

 

In the case of inactivating reagents such as monoclonal antibodies and recombinant proteins, we may need to evaluate the removal of specific virus strains or viral copy number in the presence of spiked test articles. Our experts can help determine the appropriate spike ratio and dilutions required to quench the effects of the agent, enabling the samples to be titrated.

To see all viral clearance assays use the search tool to the right or click here.

 

How many types of cultured cell-specific viral clearance studies are offered?

Process development for biologicals is often centered around mammalian cell culture for the production of monoclonal antibodies and recombinant proteins.  Each cell type has on its own associated viral strains that must be tested for virus clearance prior to IND submission.

BioReliance CRO teams offer specific viral safety tests for most common cell types used in the production of biologicals including:

  • CHO
  • Vero
  • MDCK
  • 293 Cells. . .and many more

 

Assessment of cytotoxicity to mammalian cells in culture is required for some biologicals including monoclonals and recombinant proteins prior to viral clearance. BioReliance experts are happy to provide advice on which cell lines require cytotoxicity testing prior to viral clearance.

To see all Cell types we have for viral clearance assays use the search tool to the right or click here.

 

Does BioReliance offer Baculovirus clearance testing?

Yes, we offer dedicated viral clearance studies for recombinant proteins produced by baculovirus expression systems. As well as cytotoxicity screening of test articles to SF9 cells (host cells for baculovirus).

To see baculovirus-specific viral clearance assays use the search tool to the right or click here.